Z-3182-2018 Class II Terminated
FDA device recall Z-3182-2018 was initiated by Mako Surgical Corporation on December 27, 2017 and is designated Class II. Reason for recall: Communication-connection error. The recall status is terminated (terminated December 14, 2020). Affected quantity: 736 (US) and 174 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- December 27, 2017
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 736 (US) and 174 (OUS)
Product Description
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Reason for Recall
Communication-connection error.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,
Code Information
ALL LOTS